Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Information source: University of Washington
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genital Herpes
Intervention: acyclovir (Drug); acyclovir (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Karen Mark, MD, MPH, Principal Investigator, Affiliation: University of Washington
Overall contact:
Karen Mark, MD, MPH, Phone: 206-720-4340, Email: suppression@u.washington.edu
Summary
The purpose of this study is to determine what effect suppressive therapy has on sexual
behavior and quality of life among persons with genital herpes (HSV) who have multiple sex
partners.
Clinical Details
Official title: Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission
Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: To determine the effect of suppressive antiviral therapy on sexual behavior among HSV-2 seropositive persons with multiple sexual partners.
Secondary outcome: To examine the acceptability and adherence to suppressive antiviral therapy for HSV-2 prevention among single, sexually active men and women.
Detailed description:
We plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg
orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes
recurrences. We will enroll 500 HSV-2 seropositive single persons (250 per arm), stratified
by gender and history of symptomatic genital herpes, and prospectively follow them for 1
year to assess sexual behavior, adherence to therapy, and herpes-related quality of life.
These outcomes will be measured by self-report in a confidential, computer-based assessment.
We plan to use data from this trial to model the effect that increasing the proportion of
sexually-active HSV-2 infected persons taking suppressive therapy will have on
population-level incidence and prevalence of HSV-2.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18 years or older
- HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from
anogenital site
- 2 or more vaginal or anal sex partners in the past 12 months
- Not currently in a monogamous sexual relationship of >= 6 months duration
- Willing and able to be randomized and comply with the study protocol
Exclusion Criteria:
- Pregnancy or intention to become pregnant within the next year
- Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of
enrollment/randomization
- 6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months
prior to starting suppressive therapy if on suppressive therapy during the prior 12
months
- HIV seropositive or known immunocompromising medical condition. HIV negative test
must be performed within 60 days of Visit 1 (enrollment/randomization). For current
or former participants in HIV vaccine clinical trials for whom HIV vaccine-induced
seropositivity potentially leading to vaccine study unblinding may be a concern, a
report from the Seattle HVTU documenting that the participant is HIV uninfected based
on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing
done at our clinic.
- Intention to move from the Seattle area within the next year
- Known allergy, intolerance, or medical contraindication to acyclovir
- Inability to understand, speak, and read English
Locations and Contacts
Karen Mark, MD, MPH, Phone: 206-720-4340, Email: suppression@u.washington.edu
University of Washington Virology Research Clinic, Seattle, Washington 98122, United States; Recruiting
Selin Caka, Phone: 206-720-4340, Email: scaka@u.washington.edu
Karen Mark, MD, MPH, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: September 2012
Last updated: August 31, 2009
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